Clinical trial: the glucagon-like peptide-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome: a randomized, placebo-controlled, double-blind study.
BACKGROUND
There is currently no treatment available to manage acute pain attacks in IBS patients regardless of subtype.


OBJECTIVE
To evaluate efficacy and safety of the GLP-1 analogue ROSE-010 in patients with irritable bowel syndrome (IBS) through a randomized, double-blind, placebo-controlled study.


METHODS
Eligible patients (n = 166) meeting Rome II criteria were randomly assigned to receive single subcutaneous injections of ROSE-010 100 microg, 300 microg and placebo in a cross-over design. Safety was assessed from spontaneously reported adverse events and measurement of vital signs. Patient-rated pain relief and intensity were measured on a 100-mm visual analogue scale. The primary efficacy variable was proportion of patients with >50% maximum total pain relief response from 10 to 60 min after treatment. Secondary endpoints included the maximum summed pain intensity difference, time to meaningful pain relief and patient ratings of satisfaction with treatment.


RESULTS
Twice as many patients were responders in the primary efficacy endpoint after both ROSE-010 injections compared to placebo (24%P = 0.011, 23%P = 0.005, and 12% after 300 microg, 100 microg and placebo injections, respectively). Similar results were obtained for the proportion of patients with total pain intensity response. Times to meaningful and total pain relief were shorter for both doses of ROSE-010 compared with placebo. Compared with placebo, more patients (P < 0.05) were satisfied with ROSE-010 and considered ROSE-010 better than previous IBS medications used.


CONCLUSIONS
ROSE-010 was well tolerated and provided fast and effective relief of acute pain attacks on demand in IBS patients.
Hellström
P M
PM
Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Solna, Sweden. per.hellstrom@ki.se
Hein
J
J
Bytzer
P
P
Björnssön
E
E
Kristensen
J
J
Schambye
H
H
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D055104:Infusions, Subcutaneous; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain; D010147:Pain Measurement; D016896:Treatment Outcome
D052216:Glucagon-Like Peptide 1